Background: Despite decades of advocacy to improve informed consent for human subjects, multiple studies have shown that research subjects often do not understand fundamental concepts required for participation. Over the past decade we have developed and tested embodied conversational agents (ECA) - computer characters that simulate face-to-face conversation using voice, hand gesture, gaze cues and other nonverbal behavior in both English and Spanish. We have also pilot tested the use of the ECA platform as a method of supporting the informed consent process for potential research subjects. We now propose to adapt this innovative cutting edge technology to create and test the Research Ethics and Safety Promoted by Embodied Conversational Technology (RESPECT) system which will: (1) improve the way potential subjects learn about research studies (ECA-Study Finder);(2) help make informed consent for potential research subjects more meaningful (ECA-Consent Advocate);and (3) improve the experience of research subjects (ECA-Study Buddy). Design: Randomized Controlled Trial Hypotheses: That RESPECT system participants will: (1) have a better study finder experience;(2) have better comprehension of informed consent;(3) be more adherent to the study protocol;and (3) report more adverse events. Population Studied: Users of a study finder system and people being approached for enrollment into a set of oncology studies and Boston Medical Center. Methods: The ECA-Study Finder will be assessed with a randomized controlled trial of people who use either a text-based or ECA-based study finder system. The ECA-Consent Advocate and ECA-Study Buddy components will be assessed with a randomized controlled trial of 102 patients over 18 years old, who are being approached to participate in an oncology trial at Boston University Medical Center. Outcome Measures: The primary outcome is level of comprehension of informed consent. Secondary outcomes for the study finder include accuracy of the text-based versus ECA-based study finder process. Secondary outcomes for the consent advocate include likelihood to enroll and satisfaction. Secondary outcomes for the study-buddy system include adherence to the study protocol, reporting more adverse events, and satisfaction. Expected Results: In this project we will evaluate a scalable patient-centered intervention to make it easier for people to search for research studies, improve the quality of informed consent, improve adherence to research protocols, and promote better reporting of adverse events.

Public Health Relevance

Despite decades of advocacy to improve informed consent for human subjects, multiple studies have shown that research subjects often do not understand fundamental concepts required for participation. In this project we will advance our research toward the development of a scalable, cost-effective, and sustainable patient-centered Embodied Conversational Technology intervention to make it easier for people to search for research studies, improve the quality of informed consent, improve adherence to research protocols, and promote better reporting of adverse events.